Opioid-sparing pain plan after anterior total hip replacement
Opioid-Sparing Joint Replacement - Single Site Randomized Control Trial
This study will test whether a reduced-opioid pain plan after anterior total hip replacement lowers opioid use while keeping pain well controlled for adults with osteoarthritis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT07348627 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind phase 3 trial enrolls adults undergoing anterior total hip arthroplasty for osteoarthritis who will receive a standardized multimodal non-opioid analgesic regimen and counseling from a Life Care Specialist. At discharge participants are randomized to receive either a standard opioid prescription or placebo tablets, with a limited supply of rescue hydromorphone available for severe breakthrough pain. Pain scores, nausea, opioid consumption, and patient-reported outcomes are collected during the first postoperative week and at follow-up visits at 3 weeks and 3 months. The study is designed to determine whether limiting routine opioid prescriptions after hip arthroplasty can safely reduce opioid exposure without compromising recovery or patient satisfaction.
Who should consider this trial
Good fit: Adults with hip osteoarthritis scheduled for primary anterior total hip arthroplasty who can provide informed consent, comply with study procedures, and have not used opioids within four weeks before surgery are the intended participants.
Not a fit: Patients with recent opioid use, chronic pain syndromes (such as fibromyalgia), high pain-catastrophizing scores, significant organ dysfunction, or other protocol exclusions are unlikely to benefit from this opioid-limited discharge strategy.
Why it matters
Potential benefit: If successful, the approach could lower opioid exposure after hip replacement, reducing side effects and the risk of long-term dependence while preserving pain control.
How similar studies have performed: Multimodal, opioid-sparing strategies have shown promise in reducing opioid requirements and side effects after joint replacement in prior studies, though fully blinded, post-discharge randomized trials specifically in anterior THA are relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of hip osteoarthritis requiring primary arthroplasty * Scheduled to undergo anterior total hip arthroplasty (THA) * Able to comply with study procedures and follow-up visits * Able to provide informed consent Exclusion Criteria: * Concurrent significant injuries to other bones or organs * Local infection at or near the surgical site * Preoperative opioid use within 4 weeks prior to surgery * History of severe heart disease (NYHA Class II or higher), renal failure, or liver dysfunction * Chronic liver disease * Neurological or psychiatric conditions that may influence pain perception * Pregnancy * History of alcohol or medication abuse * Inability to take NSAIDs * Use of postoperative DVT prophylaxis other than aspirin 81 mg twice daily * Diabetes mellitus with HbA1c \> 8.0% * Diagnosis of chronic pain syndrome or fibromyalgia * Pain Catastrophizing Scale (PCS) score \> 29 * Any condition that, in the investigator's judgment, may interfere with adherence to study procedures or follow-up
Where this trial is running
Atlanta, Georgia
- Emory University Orthopedics and Spine Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Ajay Premkumar, MD — Emory University
- Study coordinator: Ajay Premkumar, MD
- Email: ajay.premkumar@emory.edu
- Phone: 404-778-3350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.